FDA Recall Terminated

Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

Recall: Z-2208-2012 · Initiated July 11, 2012

Recall

Recall Number
Z-2208-2012
Event Number
62568
Firm
Philips Healthcare Inc.
FEI Number
1218950
Product Code
IXR
Status
Terminated
Root Cause
Equipment maintenance
Initiated
July 11, 2012
Posted
August 15, 2012
Terminated
January 23, 2017
Address
3000 Minuteman Road, Andover, MA, 01810

Description

Philips Easy Diagnost Classic-Stationary x-ray system Catalog Numbers: 70642, 70643, 706030, 706031, 706032 Stationary x-ray system, Universal RF system for general use.

Reason

Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.

Action

Philips issued an Urgent Field Safety Notice dated July 9, 2012, to notify users that the inclination swtich may be mounted incorrectly. A Field Safety Engineer will be dispatched to verify if a switch was installed properly, and in the event it was not installed properly they will re-install it properly. The Field Service Engineer will add a label as described in the spare part replacement manual, which is part of the FCO kit.. Customers were instructed review the information contained in the Field Safety Notice and to retain a copy of the notice with the equipment Instruction for Use. For further questions customers were instructed to call their Phillips representataive Technical Support Line at 1-800-722-9377. For questions regarding this recall call 978-687-1501

Distribution

Worldwide Distribution - USA including IN, MA, MI, MO, NC, NY PA, SC, and WI and to the countries of Canada, HongKong, New Zealand.

Quantity

12 units